Nicotine Dependence, Cigarettes, With WithdrawalPhase 2CIGARNCT02042521
A Dietary Supplement for Early Cigarette Withdrawal
A Phase 2 study testing Dietary Supplement in people with Nicotine Dependence, Cigarettes, With Withdrawal, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood during early cigarette withdrawal. This study will also assess whether the dietary supplement will be well tolerated during early cigarette withdrawal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence, Cigarettes, With Withdrawal
- What is being tested?
- Dietary Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- males and females
- age 18-65
- generally good physical health
- not using any illicit substances
- smoke on average at least 20 cigarettes/day.
Who cannot join
- Recent history of myocardial infarction and / or stroke
- active substance abuse except for nicotine and active fluctuant medical conditions. (present and ongoing within 3 months)
- Score of higher than 7 on the 17- item Hamilton Depression Rating Scale
- Positive results for the pregnancy testing done on the first assessment visit.
- A specific allergy to fruit-based ingredient.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood during early cigarette withdrawal. This study will also assess whether the dietary supplement will be well tolerated during early cigarette withdrawal.
Read the detailed description
100 subjects who smoke at least 20 cigarettes per day will come in on two different days, at least one week apart, in a randomized, double blind, within subject, placebo controlled design. On each day subjects will refrain from smoking cigarettes for 8 hours. On one day subjects will take the active DS (taken in two doses, the evening dose is taken at 22:00 of the night before the test day and the morning dose is taken at 8:00 of the test day) and on the other day subjects will take placebo (also taken in two doses at the same time points of the active DS). Mood symptoms and symptoms of cigarette withdrawal will be compared across the two different days. Measures of mood symptom monitoring will include self report on a scale of 1 to 10, standardized rater questions about mood, and 6 hours into withdrawal, a standardized mood induction will be done with mood assessment. Symptoms of cigarette withdrawal will be assessed over the duration of withdrawal with applied standardized rating scales by trained raters. For the first 15 - 30 subjects, on each day, a health assessment of a physical exam and blood work will be completed at the end of the withdrawal period on both test days as well as for the initial assessment appointment.
- Being tested
- Dietary Supplement, Lactose Placebo
- Keywords
- Cigarette, Withdrawal, Nicotine
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary SupplementDrug
The active evening dietary supplement is taken at 22:00. The active morning dietary supplement is taken at 8:00-8:15. The active evening dietary supplement is taken first. The active morning and evening dietary supplements are taken within 12 hours in time points as specified above.
Lactose PlaceboDrug
Also called Placebo
This research study involves a placebo dietary supplement that does not have any of or only partial of the active ingredients in the active dietary supplement. The placebo dietary supplement will be given in identical time points to match that of the active dietary supplements.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Smokers (Active then Placebo) | Experimental | Healthy individuals who smokes at least 20 cigarettes per day
Interventions: Dietary Supplement, Lactose Placebo Receives: Drug: Dietary Supplement; Drug: Lactose Placebo |
| Healthy Smokers (Placebo then Active) | Experimental | Healthy individuals who smokes at least 20 cigarettes per day
Interventions: Dietary Supplement, Lactose Placebo Receives: Drug: Dietary Supplement; Drug: Lactose Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Visual Analog Scale as Compared to Baseline Compared Across Two Conditions
VAS uses a 10-cm scale for participants to indicate the extent to which each of them feel happy or sad. The change in VAS before versus after sad mood induction is the change score in VAS. The change score on the day with active dietary supplement is compared to the change score on the day with the placebo dietary supplement.
Measured: Two sessions at least one week apart
Secondary outcomes (2)
Potential Side Effects Questionnaire
Structured questionnaires to assess the potential occurrence of side effects from Component A and Component B of the DS. In general, reported Component A side effects are fairly minor. Some of the reported side effects include nausea, headaches, fatigue, heartburn and joint pain. Reported side effects with Component B include: drowsiness, nausea and headaches, dizziness, fatigue, and lethargy
Measured: Twice on both test days: once in the morning right before the morning active or placebo dietary supplement and once more right after the observed break
Profile of Mood States
The POMS contains 65 adjectives rated by participants on a 5-point scale. Six factors are derived that include tension, depression, anger, fatigue, vigor and confusion.
Measured: Anytime during initial assessment visit. On both test days, at least 1 week apart at: (7:35-8:00); (8:40-9:05); (11:20-11:45); (12:25-12:50); (13:10-13:30); (14:30-14:55)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Dependence, Cigarettes, With WithdrawalStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Meyer, Centre for Addiction and Mental Health
- Investigators
- Jeffrey H. Meyer, MD, PhD, Principal investigator, Research Imaging Centre, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042521
- Sponsor's protocol ID
- 021 / 2013
- Acronym
- CIGAR
- Status last verified
- Feb 2018
- First submitted
- 16 Jan 2014
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dietary Supplement for Early Cigarette Withdrawal
- ClinicalTrials.gov ID
- NCT02042521
- Acronym / sponsor ID
- CIGAR / 021 / 2013
- Keywords
- Cigarette, Withdrawal, Nicotine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood during early cigarette withdrawal. This study will also assess whether the dietary supplement will be well tolerated during early cigarette withdrawal.
Detailed description
100 subjects who smoke at least 20 cigarettes per day will come in on two different days, at least one week apart, in a randomized, double blind, within subject, placebo controlled design. On each day subjects will refrain from smoking cigarettes for 8 hours. On one day subjects will take the active DS (taken in two doses, the evening dose is taken at 22:00 of the night before the test day and the morning dose is taken at 8:00 of the test day) and on the other day subjects will take placebo (also taken in two doses at the same time points of the active DS). Mood symptoms and symptoms of cigarette withdrawal will be compared across the two different days. Measures of mood symptom monitoring will include self report on a scale of 1 to 10, standardized rater questions about mood, and 6 hours into withdrawal, a standardized mood induction will be done with mood assessment. Symptoms of cigarette withdrawal will be assessed over the duration of withdrawal with applied standardized rating scales by trained raters. For the first 15 - 30 subjects, on each day, a health assessment of a physical exam and blood work will be completed at the end of the withdrawal period on both test days as well as for the initial assessment appointment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Smokers (Active then Placebo) | Experimental | Drug: Dietary Supplement, Drug: Lactose PlaceboHealthy individuals who smokes at least 20 cigarettes per day Interventions: Dietary Supplement, Lactose Placebo |
| Healthy Smokers (Placebo then Active) | Experimental | Drug: Dietary Supplement, Drug: Lactose PlaceboHealthy individuals who smokes at least 20 cigarettes per day Interventions: Dietary Supplement, Lactose Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- males and females
- age 18-65
- generally good physical health
- not using any illicit substances
- smoke on average at least 20 cigarettes/day.
Key exclusion criteria (5 listed)
- Recent history of myocardial infarction and / or stroke
- active substance abuse except for nicotine and active fluctuant medical conditions. (present and ongoing within 3 months)
- Score of higher than 7 on the 17- item Hamilton Depression Rating Scale
- Positive results for the pregnancy testing done on the first assessment visit.
- A specific allergy to fruit-based ingredient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary SupplementThe active evening dietary supplement is taken at 22:00. The active morning dietary supplement is taken at 8:00-8:15. The active evening dietary supplement is taken first. The active morning and evening dietary supplements are taken within 12 hours in time points as specified above. | Drug | Healthy Smokers (Active then Placebo), Healthy Smokers (Placebo then Active) |
| Lactose PlaceboAlso: PlaceboThis research study involves a placebo dietary supplement that does not have any of or only partial of the active ingredients in the active dietary supplement. The placebo dietary supplement will be given in identical time points to match that of the active dietary supplements. | Drug | Healthy Smokers (Active then Placebo), Healthy Smokers (Placebo then Active) |
Primary outcome
Change in the Visual Analog Scale as Compared to Baseline Compared Across Two Conditions
Time frame: Two sessions at least one week apart
VAS uses a 10-cm scale for participants to indicate the extent to which each of them feel happy or sad. The change in VAS before versus after sad mood induction is the change score in VAS. The change score on the day with active dietary supplement is compared to the change score on the day with the placebo dietary supplement.
2 secondary outcomes
Potential Side Effects Questionnaire
Time frame: Twice on both test days: once in the morning right before the morning active or placebo dietary supplement and once more right after the observed break
Profile of Mood States
Time frame: Anytime during initial assessment visit. On both test days, at least 1 week apart at: (7:35-8:00); (8:40-9:05); (11:20-11:45); (12:25-12:50); (13:10-13:30); (14:30-14:55)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey H. Meyer, MD, PhD principal investigator
Research Imaging Centre, Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dietary Supplement in people with Nicotine Dependence, Cigarettes, With Withdrawal, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Visual Analog Scale as Compared to Baseline Compared Across Two Conditions (time frame: Two sessions at least one week apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.